Midline Catheter Dressing Change Kit with Statlock — Class II medical device recall Z-1468-2021
Terminated recall by Trinity Sterile, Inc., reported 2021-04-28, distributed nationwide. Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised s
| Recall number | Z-1468-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trinity Sterile, Inc., Salisbury, MD, United States |
| Recall initiated | 2021-02-23 |
| Classified | 2021-04-21 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,970 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00841767107942 |
| Lot numbers | 600001 |
Product
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Reason for recall
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1468-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.